Replacement semilunar heart valves using flexible tubes

• US 6,270,526 B1
• Filed: 03/27/2000
• Issued: 08/07/2001
• Est. Priority Date: 11/01/1993
• Status: Expired due to Term

• Current Assignee: 3F Therapeutics Incorporated (Medtronic Plc)
• Original Assignee: 3F Therapeutics Incorporated (Medtronic Plc)
• Inventors: Cox, James L.
• Primary Examiner(s): Isabella, David J.
• Assistant Examiner(s): Koh, Choon P.
• Application Number:
  US09/536,229
• Time in Patent Office: 498 Days
• Field of Search: 623/2.1, 623/2.13, 623/2.12, 623/900, 623/901
• US Class Current: 623/2.12
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3629 Intestinal tissue, e.g. small intestinal submucosa
• CPC Class Codes: A61L 27/3641 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/3645 Connective tissue
• CPC Class Codes: A61L 27/3843 Connective tissue
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: G06Q 40/04 Trading; Exchange, e.g. stocks, commodities, derivatives or currency exchange
• CPC Class Codes: Y10S 623/90 Stent for heart valve
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

A method is disclosed for using tubular material to replace a semilunar heart valve (i.e., an aortic or pulmonary valve). To create such a replacement valve, the native valve cusps are removed from inside an aorta or pulmonary artery, and the inlet end of a tubular segment is sutured to the valve annulus. The outlet (distal) end of the tube is either “tacked” at three points distally, or sutured longitudinally along three lines; either method will allow the flaps of tissue between the suture lines to function as movable cusps. This approach generates flow patterns that reduce turbulence and closely duplicate the flow patterns of native semilunar valves. An article of manufacture is also disclosed, comprising a sterile biocompatible synthetic material which has been manufactured in tubular form, by methods such as extrusion or coating a cylindrical molding device, to avoid a need for a suture line or other seam to convert a flat sheet of material into a tubular shape. The synthetic tube is packaged within a sealed watertight enclosure that maintains sterility of the tube.

Claims

1. A replacement semilunar heart valve for placement in a ventricular outflow artery of a patient, comprising:

an elongate, substantially tubular segment comprising;

a thin and flexible wall portion with diametrically opposing sides;

an inlet end and an outlet end, the inlet end sized and adapted to be circumferentially secured substantially flush with a valve annulus formed by removing a native semilunar heart valve;

three securement points adjacent the outlet end and spaced from each other, the securement points adapted to be attached to a wall of the artery; and

three unconstrained regions between the securement points, each of the unconstrained regions adapted to flex inwardly into and out of engagement with others of the unconstrained regions.

2. A heart valve as in claim 1, wherein at least a portion of the outlet end is adapted to be spaced from the artery wall when the valve is open.

3. A heart valve as in claim 1, wherein the securement points are positioned so as to engage the artery wall at substantially the same locations vacated by cusps of the removed native valve.

4. A heart valve as in claim 1, wherein the outlet end is slightly scalloped.

5. A heart valve as in claim 1, wherein the securement points are about 120°

apart.

6. A heart valve as in claim 1, additionally comprising longitudinal suture lines substantially aligned with the securement points.

7. A heart valve as in claim 1, wherein the wall portion comprises pinched junctures at the securement points.

8. A heart valve as in claim 2, additionally comprising reinforcements adjacent the securement points.